Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT06216795
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2024-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kidney Volume in Live Donors Kidney Transplant Donors and Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction models for the residual renal function of donors and the graft kidney function of recipient after live donor kidney transplantation', 'timeFrame': '1 and 3 years after transplantation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '39116451', 'type': 'DERIVED', 'citation': 'Jo EA, Lee J, Moon S, Kim JS, Han A, Ha J, Kim YC, Min S. The role of artificial intelligence measured preoperative kidney volume in predicting kidney function loss in elderly kidney donors: a multicenter cohort study. Int J Surg. 2024 Nov 1;110(11):7169-7176. doi: 10.1097/JS9.0000000000002030.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to investigate the association between renal volume measured through pre-donation CT auto-segmentation and postoperative renal function of both donors and recipients. After establishing the statistical significance of the association, the investigators intend to create and validate predictive models for renal function at surgery, 1 year, and 3 years postoperatively, incorporating various factors known to contribute to renal function deterioration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'live kidney donors and paired their recipients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* live donor kidney transplant\n\nExclusion Criteria:\n\n* donors without preoperative enhanced CT image'}, 'identificationModule': {'nctId': 'NCT06216795', 'briefTitle': 'Kidney Volume in Live Donors Kidney Transplant Donors and Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Measurement of Kidney Volume Using Computed Tomography in Kidney Transplant Donors and Recipients', 'orgStudyIdInfo': {'id': 'SNUH-Kidney Volumetry_KT_v1.3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'kidney transplant group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Il Min, MD', 'role': 'CONTACT', 'email': 'surgeonmsi@gmail.com', 'phone': '82-2-2072-2330'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sangil Min, MD, PhD', 'role': 'CONTACT', 'email': 'surgeonmsi@gmail.com', 'phone': '01071739341'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Severance Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}